cancer cachexia
Conditions
Interventions
treatment group:use Kanglaite Injection
Sponsors
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed patients with stage III-IV non-small cell lung cancer (adenocarcinoma), colorectal carcinoma or pancreatic carcinoma, who are not eligible for surgery, interventional treatment and radiation therapy; 2) Confirmed patients with cachexia: weight loss greater than 5% in last six months, or BMI<20kg/m2 and weight loss greater than 2%, or in accordance with the diagnosis of sarcopenia and weight loss greater than 2%; 3) Patients who are not being treated with chemotherapy should have completed chemotherapy 14 days before randomization of this study; 4) For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period; 5) Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations; 6) ECOG PS 0-3 for those who are not treated with chemotherapy; and ECOG PS 0-2 for those who are being treated with chemotherapy; 7) Expected survival period is more than 4 months; 8) Male or female aged 18 - 75 years; 9) Patients who are willing to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Any pathological type of non-small cell lung cancer (NSCLC) except adenocarcinoma; 2) Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol; 3) Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction (AST/ALT >5 times the ULN), severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, NYHA class III-IV heart failure, AIDS etc.; 4) Any condition that may hinder the subject’s completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.; 5) Patients who are being treated with other anticancer traditional Chinese medicine (TCM), or those who may be treated with TCM after enrollment; 6) Patients with severe hepatic dysfunction: Scr >=1.5 times the ULN, ALT/AST/ALP >=5 times the ULN, TBIL >=1.5 times the ULN; 7) Patients with severe abnormal lipid metabolism (TC>300mg/dl or TG >2.5 times the ULN), or those who are in lipid-lowering therapy; 8) Known or suspected diagnosis of metastatic encephaloma; 9) In treatment of or plan to receive treatment of molecular targeted drugs, eg, EGFR-TKI, ALK inhibitor, anti-angiogenic agents (including monoclonal antibodies and endostatin), and cetuximab; 10) Patients present with an ECOG score>2 and require treatment of chemotherapy; 11) Patients with allergies or intolerability to the investigational product or its excipients; 12) Patients who are currently included in other clinical trials on antineoplastic drugs; 13) Patients who are not able to provide the ICF; 14) Expected survival period is less than 4 months; 15) Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception (including males); 16) Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder; 17) Any condition, in the investigator's opinion, is not in the best interest of the subject (e.g., harming the subject's health) or potentially interferes with the evaluation of treatment according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight;lean body mass; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS rate;ECOG score;QOL score;survival curve;OS;BMI;Serum albumin;Serum Prealbumin;Serum Lactic Acid;grip strength of non dominant hand; | — |
Countries
China
Contacts
Public ContactShiying Yu
Outcome results
None listed